B Braun Medical Inc: B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

Recall number

Z-1799-2026

Recalling firm

B Braun Medical Inc

Product

B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096

Status

Open, Classified

Initiated

2026-03-19

Posted

2026-04-15

Terminated

not on file

Reason

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.

Root cause

Device Design

Action

B. Braun notified consignees on about 03/19/2026 via letter titled URGENT MEDICAL DEVICE CORRECTION. Consignees were instructed to use alternative dialysis equipment and disposables, if possible. If not, BBMI recommends the following actions that can help mitigate potential harm should you need to use sets impacted by this field action on patients: 1. Ensure full adherence to both the bloodline and dialysis machine Instructions for Use (IFU). a. Streamline bloodlines - strict adherence to the priming process as outlined in the IFU, with special emphasis on Step 26. b. B3 bloodlines - strict adherence to the priming process as outlined in the IFU, with special emphasis on Step 12. 2. If possible, avoid high flow during treatment if small air bubbles are present. 3. Avoid retrograde rinseback if small air bubbles are present. 4. Be alert for a follow-up communication indicating the issue is resolved. Consignees were also instructed to review the customer notification its entirety, ensure all affected personnel are notified and aware of the issue, post the notification where the affected products are stored, and complete and return the response form. For distributors, they were instructed to forward the notification to all consignees as this recall extends to the consumer level. B. Braun will provide a follow up communication to users when lots with corrective actions are available, and users may resume high flow treatment and use of retrograde rinseback where indicated.

Quantity

2,653,711 units

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Lot, serial or model codes

Model Number: SL-2010M2096; UDI-DI Primary: 04046964367786; UDI-DI Unit: 04046964367779; All lots manufactured since 25MAY2025.

510(k) numbers

["K080807"]

PMA numbers

not on file

Product code

FJK

Firm FEI

2521402

Firm city

Bethlehem

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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